Metabolism-informed Care for Smoking Cessation

Summary

Nicotine mediates smoking's addictive effects in the brain. The ratio of 3-hydroxycotinine to cotinine, known as the nicotine metabolite ratio, or NMR, is a genetically- informed biomarker reflecting hepatic CYP2A6 activity and the rate of nicotine metabolism. In light of a recent randomized controlled trial (RCT) in humans in Lancet Respiratory Medicine, which found that the NMR can be used to individualize treatment for smokers, our pilot study aims to determine the feasibility of using NMR to guide selection of pharmacotherapy in clinical populations of daily smokers.

Conditions

• Tobacco Use
• Tobacco Use Cessation

Interventions

OTHER

Nicotine Metabolite Ratio

This intervention used information from a genetically-informed biomarker (Nicotine Metabolite Ratio, NMR) to assign one of 3 FDA-approved smoking cessation pharmacotherapies (varenicline, bupropion, or NRT) to participants.

DRUG

Varenicline

FDA-approved smoking cessation pharmacotherapy

DRUG

Bupropion

FDA-approved smoking cessation pharmacotherapy

DRUG

Nicotine patch

FDA-approved smoking cessation pharmacotherapy

Sponsors & Collaborators

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Matthew Freiberg, MD · Vanderbilt University Medical Center

• Quinn Wells, MD · Vanderbilt University Medical Center

• Dawn Beaulieu, MD · Vanderbilt University Medical Center

• Hilary Tindle, MD · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-18

Primary Completion

2016-10-08

Completion

2017-04-18